Full Press Release Details
Iovance Biotherapeutics Reports First
Quarter 2018 Financial Results and Provides Corporate Update
- Company to Host Conference Call at 4:30pm
SAN CARLOS, CA - May 10, 2018 -- Iovance Biotherapeutics,
Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL)
technology, today reported its first quarter 2018 financial results and provided a corporate update.
"Our January 2018 financing
puts us in a strong position to advance and expand our robust TIL product pipeline. We continue enrollment in our ongoing trials
and have expanded our melanoma study to enroll an additional 25 patients. We are initiating investigation of TIL therapy
in new indications as part of our collaboration with MD Anderson, and one of those studies investigating
our LN-145 TIL product in patients with sarcomas and ovarian cancers, is now active," said
Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We also recently received
orphan-drug designation from the FDA for autologous tumor infiltrating lymphocytes for the treatment of patients with cervical
cancer with a tumor size of greater than 2 cm in diameter."
and Upcoming Milestones
First Quarter 2018 Financial Results
Net loss for the quarter ended March 31, 2018 was $26.5 million,
or ($0.31) per share, compared to net loss of $20.7 million, or ($0.33) per share for the same period ended March 31, 2017.
Research and development expenses were $19.9 million for the
quarter ended March 31, 2018, an increase of $4.3 million compared to $15.6 million for the same period ended March 31, 2017. The
increase in research and development expenses was primarily attributable to a $2.2 million increase in payroll related expenses
and consulting fees due to higher head count and dedicated consultants as the Company expanded its research efforts and clinical
development programs, and a $2.0 million increase attributable to higher clinical trial costs due to an increase in patient enrollment
and an increase in the number of clinical sites for the clinical trial of the Company's lead product candidate, LN-144, for
the treatment of metastatic melanoma, and the initiation of clinical trials of LN-145 for the treatment of cervical, head and neck
cancers in 2017. These increases were partially offset by a $1.0 million decrease in manufacturing costs due to higher costs in
2017 related to technical transfer activities.
General and administrative expenses were $7.0 million for the
quarter ended March 31, 2018, an increase of $1.7 million compared to $5.3 million for the same period ended March 31, 2017. The
increase was primarily attributable to a $0.9 million increase in payroll related expenses due to an increase in head count, and
a $0.6 million increase in professional service and legal expenses primarily to support the expansion of the Company's intellectual
At March 31, 2018, the company held $297.1 million in cash and
cash equivalents, compared to $145.4 million at December 31, 2017. The company anticipates that the year-end balance of cash, cash
equivalents and short-term investments may be between $190 to $210 million.
Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to
discuss these first quarter 2018 results and provide a corporate update. The conference call dial-in numbers are: 1-844-646-4465
(domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 2995797. The live webcast can be
accessed under "News & Events" in the "Investors" section of the company's website at http://www.iovance.com/
or you may use the link: https://edge.media-server.com/m6/p/ouykqu6a.
A replay of the call will be available
from May 10, 2018 at 7:30 p.m. ET to May 17, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic)
or 1-404-537-3406 (international). The conference ID number for the replay is 2995797. The archived webcast will be available
for thirty days in the Investors section of Iovance Biotherapeutics' website at http://www.iovance.com.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is a clinical-stage biotechnology
company focused on the development of cancer immunotherapy products for the treatment of various cancers. The company's lead product
candidate is an adoptive cell therapy using tumor-infiltrating lymphocyte (TIL) technology being investigated for the treatment
of patients with metastatic melanoma, recurrent and/or metastatic squamous cell carcinoma of the head and neck, recurrent, metastatic
or persistent cervical cancer, and locally advanced or metastatic non-small cell lung cancer. For more information, please visit http://www.iovance.com.
Forward-Looking Statements
Certain matters discussed in this press release are "forward-looking
statements". We may, in some cases, use terms such as "predicts," "believes," "potential,"
"continue," "estimates," "anticipates," "expects," "plans," "intends,"
"may," "could," "might," "will," "should" or other words that convey
uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company's statements
regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements
include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and
anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion
of these trials; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority
approval of, or other action with respect to, our product candidates; the strength of Company's product pipeline; the successful
implementation of the Company's research and development programs and collaborations; the success of the Company's
license or development agreements; the acceptance by the market of the Company's product candidates, if approved; and other
factors, including general economic conditions and regulatory developments, not within the Company's control. The factors
discussed herein could cause actual results and developments to be materially different from those expressed in or implied by
such statements. A further list and description of the Company's risks, uncertainties and other factors can be found in
the Company's most recent Annual Report on Form 10-K and the Company's subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online at www.sec.gov or www.iovance.com.
The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to
publicly update such forward-looking statements to reflect subsequent events or circumstance.
Investor Relations Contact:
Stern Investor Relations, Inc.
Media Relations Contact:
| IOVANCE BIOTECHNOLOGIES, INC. |
| Selected Consolidated Balance Sheet Data |
| (In thousands) |
| (Unaudited) | (Audited) | |||||||
| March 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Cash, and cash equivalents | $ | 297,082 | $ | 145,373 | ||||
| Total assets | $ | 307,248 | $ | 155,373 | ||||
| Stockholders' equity | $ | 292,558 | $ | 145,481 |
| Consolidated Statements of Operations |
| (Unaudited, in thousands, except per share data) |
| For the Three Months March 31, | ||||||||
| 2018 | 2017 | |||||||
| Revenues | $ | - | $ | - | ||||
| Costs and expenses* | ||||||||
| Research and development expenses | 19,912 | 15,593 | (1) | |||||
| General and administrative expenses | 6,965 | 5,289 | (1) | |||||
| Total costs and expenses | 26,877 | 20,882 | ||||||
| Loss from operations | (26,877 | ) | (20,882 | ) | ||||
| Other income | ||||||||
| Interest income | 362 | 198 | ||||||
| Net Loss | $ | (26,515 | ) | $ | (20,684 | ) | ||
| Net Loss Per Common Share, Basic and Diluted | $ | (0.31 | ) | $ | (0.33 | ) | ||
| Weighted-Average Common Shares Outstanding, Basic and Diluted | 84,350 | 62,286 | ||||||
| * Includes stock-based compensation as follows | ||||||||
| Research and development | $ | 2,000 | $ | 1,250 | (1) | |||
| General and administrative | 2,104 | 2,046 | (1) | |||||
| $ | 4,104 | $ | 3,296 |